Mass Balance and Metabolic Profiling of [14C]AZD5672 in Healthy Male Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00711074
Recruitment Status : Completed
First Posted : July 8, 2008
Last Update Posted : April 9, 2009
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Brief Summary:
The purpose of this study is to determine how the body breaks down and excretes the investigational drug, AZD5672.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: AZD5672 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open-Label, Phase I Study to Assess the Excretion of Radioactivity, Metabolic Profiles and Pharmacokinetics Following a Single Oral Dose of [14C]AZD5672 in Healthy Male Volunteers
Study Start Date : June 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: AZD5672
single dose 200mg aqueous solution

Primary Outcome Measures :
  1. total radioactivity in plasma, whole blood, faeces and urine. [ Time Frame: Pre-dose, post dose, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2, 3, 4, 6, 9, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240h ]
  2. Additional metabolite identification [ Time Frame: 0.5h, 3h, 6h, 12h, 24h ]

Secondary Outcome Measures :
  1. general safety assessments: AE reporting, physical examination, ECG, safety haematology and clinical chemistry assessment, vital signs [ Time Frame: Screening, pre-dose, Visit 2 (residential period) and visit 3 follow up ]

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Body Mass index (BMI) 18-30 kg/m2, inclusive.
  • Clinically normal findings in physical examination, ECG, vital signs, clinical chemistry, haematology & urinalysis, as judged by the investigator

Exclusion Criteria:

  • Healthy volunteers who have been exposed to radiation levels above background (eg through X-ray examination) of >5 mSv in the last year, >10 mSv over the last 5 years or a cumulative total of >1 mSv per year of life
  • Clinically significant illness within the 2 weeks prior to dosing, as judged by the investigator
  • Use of prescribed medication (including St. John's Wort) during the 3 weeks prior to dosing or use of over the counter drugs (including herbals, vitamins and minerals) during 1 week prior to dosing (other than occasional paracetamol use)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00711074

United Kingdom
Research Site
Macclesfield, Cheshire, United Kingdom
Sponsors and Collaborators
Study Director: Mark Layton AstraZeneca
Principal Investigator: Raj Chetty AstraZeneca

Responsible Party: Mark Layton, MD, MRCP(UK), MFPM, Medical Science Director, Early Development RITA, AstraZeneca Pharmaceuticals Identifier: NCT00711074     History of Changes
Other Study ID Numbers: D1710C00010
2008-001528-30 (EUdract No)
First Posted: July 8, 2008    Key Record Dates
Last Update Posted: April 9, 2009
Last Verified: April 2009

Keywords provided by AstraZeneca:
mass balance

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
CCR5 Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents